Identity
- Trade Name
- Tixel Handpiece FDA UDI
- Generic Name
- Thermo-mechanical skin surface treatment system handpiece FDA UDI
- Device Name
- Standard Handpiece used with TXLD0002 FDA UDI
- Model / Reference
- THLM0002 FDA UDI
- Description
- Standard Handpiece used with TXLD0002 FDA UDI
Identifiers
- Catalog Number
- THLM0002 FDA UDI
- Primary DI / UDI-DI
- 07290117524015 FDA UDI
- 510(k) Number
- K202988 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Thermo-mechanical skin surface treatment system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermo-mechanical skin surface treatment system handpiece
Tixel Handpiece by Novoxel Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermo-mechanical skin surface treatment system handpiece.
- Tixel Periorbital Handpiece — NOVOXEL LTD · Class II
Cleared under the same submission
K202988 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novoxel Ltd
Sources (1)
- FDA UDI b047b80b-53e9-43dc-b40c-447deb4de219 35 fields · synced Jun 8, 2026